聚乙二醇α—2a干扰素健康人体安全性Ⅰ期临床试验探究.docVIP

聚乙二醇α—2a干扰素健康人体安全性Ⅰ期临床试验探究 　　解放军第三〇二医院，北京 100039 [摘要] 目的 探索聚乙二醇干扰素α-2a在中国健康受试者中的安全性与耐受性。 方法 选择10名健康受试者，每名受试者皮下注射聚乙二醇干扰素α-2a 180 μg，然后进行14 d的安全性观察。 结果 有9名受试者完成试验，共报告45次不良事件，其中包括发热7次，头痛8次，中性粒细胞降低7次，白细胞降低4次，恶心2次，头晕2次，肌肉酸痛2次，尿蛋白异常2次，尿酮体异常2次，乏力1次，纳差1次，发冷1次，腹部隐痛1次，腰痛1次，双眼刺痛1次，ALP异常1次，血钾异常1次，其中发热、头痛、恶心、头晕、肌肉酸痛、乏力、纳差、发冷、腰痛、白细胞降低、中性粒细胞降低均判断为与用药肯定有关，腹部隐痛、尿蛋白异常、双眼刺痛、ALP异常、血钾异常均判断为与用药可能有关，尿酮体异常被判断为与用药可能无关。 结论 发热、头痛、中性粒细胞降低及白细胞降低是聚乙二醇干扰素α-2a的常见不良反应，即使在短期给药中也可以明显观察到。 [关键词] 聚乙二醇α-2a干扰素；临床研究；耐受性；安全性 [中图分类号] R969.4 [文献标识码] A [文章编号] 1673-7210（2014）03（a）-0053-06 PhaseⅠclinical research on the safety of peginterferon α-2a in healthy volunteers BI Jingfeng LIU Jia ZHOU Yuxia ZHOU Peng ZHU Zhenzhen WANG Min DUAN Feng CHEN Benchao ZHANG Li WEI Zhenman 302 Military Hospital of China， Beijing 100039， China [Abstract] Objective To explore the safety and tolerance of peginterferon α-2a in healthy volunteers. Methods 10 healthy volunteers were rolled in this study and each of them was injected peginterferon α-2a 180 μg subcutaneously， then there were 14 days to observe the safety. Results A total of nine subjects completed the study， 45 adverse event were reported， including fever 7 times， headache 8 times， neutropenia 7 times， leukopenia 4 times， nausea 2 times， dizziness 2 times， aching muscles 2 times， abnormal urine protein 2 times， ketone abnormalities 2 times， fatigue once， anorexia once， chills once， abdominal pain once， back pain once， eyes stinging once， ALP abnormal once， abnormal serum potassium once. Within all the AE， fever， headache， nausea， dizziness， muscle aches， fatigue， anorexia， chills， back pain， leukopenia and neutropenia were judged as “definitely related to drug use”， abdominal pain， abnormal urine protein， eyes stinging， ALP abnormal serum potassium were determained to be “may be related to drug use”， abnormal ketone bodies are judged to be “may be unrelated”. Conclusion Fever， headache， neutropenia and leukopenia are the common adverse reactions o